Agency classClass IIOur severity:High FDA (Devices)·Z-1339-2020·Announced 2020-02-26

Siemens Ysio Max Radiographic System Recalled for Software Bug

Siemens Medical Solutions is recalling 507 Ysio Max radiographic systems because a software bug may assign one image to two different patients, potentially affecting medical diagnosis.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm to patients through potential misdiagnosis, although no specific injuries or illnesses are reported in the source text.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 507 units of the Ysio Max radiographic system, model no. 10762470. The recall is due to a software bug that may lead to one image being assigned to two different patients. This error could potentially affect medical diagnosis.

The affected systems are used in hospitals, clinics, and medical practices for radiographic and tomographic exposures of the whole body, including the skull, chest, abdomen, and extremities. The devices may be used on pediatric, adult, and bariatric patients, as well as for intravenous, small interventions, and emergency applications. The Ysio Max system is not meant for mammography.

The recall covers units distributed nationwide in the US. Specific serial numbers are listed in the official recall notice. Consumers and healthcare providers should contact Siemens Medical Solutions for further information and instructions on how to address the software issue.

The recalled product

Product: Ysio Max, model no. 10762470 - Product Usage: The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures f the whole body including: skull, chest, abdomen, and extremities and may be used on…
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Radiographic System
Hazard: software-bug
misdiagnosis
Affected units: 507

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc

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